Trial investigators implanted 48 patients with the Excor Pediatric VAD (the Berlin Heart) and compared them to matched historical controls who had received ECMO. The VAD group was composed of two 24-patient cohorts based on body-surface area. Survival was dramatically and significantly longer in both VAD cohorts:

Cohort 1 (<0.7 m2): median survival time had not been reached at 174 days in the VAD group, compared with 13 days in the ECMO group (p<0.001)

Cohort 2 (0.7 to <1.5 m2): 114 days versus 10 days (p<0.001)

However, VAD treatment was associated with clinically significant adverse events. Major bleeding occurred in 42% of cohort 1 patients and 50% of cohort 2 patients, infection in 63% and 50%, and stroke occurred in 29% of patients in both cohorts.

In an accompanying editorial, Linda Addonizio observes that the development of pediatric VADs has been markedly slower than the development of adult VADs, although “the potential number of years of life saved for each person is much greater for children.” However, because of the high rate of neurological complications she urges caution before “extending the current practice in adults of early implementation of ventricular assist devices to children.” VADs, she writes, “should remain, at present, a last resort in small children.”